Efficacy and Feasibility of an eHealth Intervention for Pregnant Women on Diet, Physical Activity and Knowledge Related to Pregnancy
NCT ID: NCT05424237
Last Updated: 2024-12-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
153 participants
INTERVENTIONAL
2022-05-01
2025-12-31
Brief Summary
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Participants are pregnancy women attended in the sanitary area number 3 of the Pincipado de Asturias. As inclusion criteria we will consider: i) aged over 18; ii) pregnant with only 1 fetus; iii) low risk pregnancy; iv) smartphone Access; v) signed the informed consent. As exclusion criteria: i) non-fluent Spanish speaker; ii) do not fill the questionnaires.
A randon sample of 153 women will be recruited consequtively, at the first triemester, from the midwife consulting room. Those women to agreed to participate, and sign the infomred consent, will be anonymizated using a alphanumerical code and asigned (according to a previous randomization distribution by code) to a control or an intervention group.
All women are going to receive the baseline and post intervention questionnaires by email. All women are going to receive the usual care. Adittionally, those in the intervention group, will be prompted to use iNATAL app.
The following questionnaires and measures will be used: uMARS Questionnaire to assess and percentage of app usage tot assess the feasibility; to assess the effectiveness: Motiva.Diaf to assess dietary and physical activity recommendations; ad hoc questionnaire to assess knwoldedge pregnancy related; mother complications during of after the pregnancy period and newborn complications.
The intervention takes all pregnancy period.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Control group
1. Sign consent form and baseline assessments
2. Usual care
3. Post intervention assessments
No interventions assigned to this group
Interention group
1. Sign consent form and baseline assessments
2. Usual care + app iNATAL
3. Post intervention assessments
App intervention
usual care plus app ussage with the aim of promote healthy behaviors (diet, physical activity and weight)
Interventions
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App intervention
usual care plus app ussage with the aim of promote healthy behaviors (diet, physical activity and weight)
Eligibility Criteria
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Inclusion Criteria
* pregnant with only 1 fetus
* low risk pregnancy
* smartphone Access
* signed the informed consent
Exclusion Criteria
* do not fill the baseline or post-intervention questionnaires
18 Years
FEMALE
No
Sponsors
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University of Oviedo
OTHER
Responsible Party
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Rubén Martín Payo
Associate professor
Locations
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University of Oviedo
Oviedo, Principality of Asturias, Spain
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2021.490
Identifier Type: -
Identifier Source: org_study_id